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The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia

NCT02300233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2022-04-13

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

Volanesorsen

300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks.

DRUG

Placebo

Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.

Sponsors & Collaborators

  • Akcea Therapeutics

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-05
Primary Completion
2016-07-27
Completion
2017-01-24
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300233 on ClinicalTrials.gov